Comparison of Two Different Endoscopic Radial Artery Harvesting Devices
Prospective Randomized Comparison of Two Different Endoscopic Radial Artery Harvesting Devices
1 other identifier
interventional
100
1 country
1
Brief Summary
Endoscopic radial artery harvesting in coronary bypass surgery is routinely performed by the investigators. In this study, the investigators want to compare the MiFusion TLS2 (Endotrust GmbH, Germany) device to the LigaSure Maryland Jaw (Medtronic, USA). The vessel harvesting is performed in the standard fashion according to the institutional routine. The patients are randomized preoperatively to one of the devices. The proximal end of the radial artery will be preserved and deep-frozen for histological assessment. Endothelial integrity will be investigated using Hematoxylin-Eosin, CD31 and endothelial nitrogen monoxide synthase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedFebruary 25, 2020
February 1, 2020
8 months
January 8, 2017
February 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Endothelial integrity of the radial artery using histological examination.
Through study completion, an average of 1 year.
Secondary Outcomes (3)
Harvesting time
The harvesting time will be measured during the vessel harvesting surgery.
Hemostasis in the arm indicated by bleeding from radial artery side branches or veins in the arm.
Intraoperatively and directly after vessel harvesting the arm is controlled using the endoscope and bleeding can be detected during this control. End of surgery is end of this outcome parameter.
Accuracy of vessel sealing, if side branches of the radial artery are bleeding after blood insufflation, additional clips have to placed at the side branch.
The blood insufflation is performed immediately after vessel harvesting and leaks can be detected.
Study Arms (2)
LigaSure endoscopic radial harvesting
ACTIVE COMPARATORThe endoscopic vessel harvesting will be performed using the LigaSure device.
TLS2 endoscopic radial harvesting
ACTIVE COMPARATORThe endoscopic vessel harvesting will be performed using the TLS2 device.
Interventions
The radial artery will be harvested endoscopically using the LigaSure system.
The radial artery will be harvested endoscopically using the TLS2 system.
Eligibility Criteria
You may qualify if:
- all adult patients undergoing CABG using the radial artery
- capability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kerckhoff Kliniklead
Study Sites (1)
Kerckhoff Klinik
Bad Nauheim, 61231, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud Van Linden, MD
Kerckhoff Klinik
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2017
First Posted
January 18, 2017
Study Start
February 1, 2017
Primary Completion
September 30, 2017
Study Completion
February 28, 2018
Last Updated
February 25, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share